Nonpharmacologic Management of Challenging Behaviors in Veterans with Dementia

描述（由申请人提供）： 超过500万美国人患有阿尔茨海默病或相关痴呆症，这是一种进行性和不可逆的神经退行性综合征，预计到2050年患病率将达到近1600万人。在65岁及以上的退伍军人中，患病率与一般人群相似，7.3%的人患有痴呆症，除了非洲裔美国人，他们的患病率高出50%。痴呆的标志是神经精神症状（例如，激动、冷漠、侵略性）。糖尿病与医疗保健费用增加、生活质量和日常功能下降、家庭照顾者负担加重和养老院安置有关。标准治疗通常涉及药物，但这些药物充其量是适度有效的，具有严重的风险，包括死亡率，并没有解决行为症状的家庭自己认为最痛苦的或提示养老院安置。这项研究解决了迫切需要开发和测试创新的非药物方法来管理老年痴呆症退伍军人。我们提出了一项III期疗效试验，以测试一种变革性的以患者为中心的干预措施，即定制活动计划（TAP），该计划涉及系统评估，以确定退伍军人的保留能力和缺陷领域，以及以前的角色，习惯和兴趣，从中定制活动。在为期4个月的多达8次家庭课程中，主要家庭照顾者接受培训，将量身定制的活动纳入日常护理程序。TAP将在随机两组平行设计中进行测试，其中160名种族和种族多样的痴呆症退伍军人及其主要家庭照顾者将被随机分配到TAP或注意力控制组，并在基线、4个月和8个月时进行访谈，以评估对痴呆症、照顾者福祉和成本的影响。我们的主要研究目的是关注患有痴呆症的退伍军人，并测试TAP在4个月时对痴呆症的直接影响。我们的假设是，与分配到注意力控制组的退伍军人相比，接受TAP的痴呆退伍军人在神经精神量表（NPI）上的总分较低，该量表评估了12种常见神经精神症状的频率和严重程度。我们还提出了四个次要目标。目的：（1）检测TAP治疗8个月后对老年痴呆患者生活质量和神经精神行为的长期影响。假设：与注意力控制组中的退伍军人相比，接受TAP的退伍军人将表现出更高的生活质量和更低的总NPI评分; 2）测试TAP在4个月时对护理人员负担的直接影响和8个月时对护理人员负担的长期影响，技能获得，使用活动的功效和提供护理所花费的时间。假设：接受TAP的护理人员将报告与对照组相比，在4个月和8个月时减轻负担，提高技能和使用活动的有效性，以及提供护理的时间更少; 3）检查接受TAP的护理人员是否在8个月时使用活动;以及4）检查TAP是否导致痴呆症退伍军人及其护理人员减少VHA医疗保健使用和费用。这些次要目标的结果将提供进一步的疗效证据，确定是否有必要进行强化治疗，并为TAP的传播工作和全系统翻译提供信息。我们的长期目标，如果证明有效，是将TAP整合到VHA系统内的标准护理实践中，作为解决居家痴呆症退伍军人的首选治疗方法。这将改变目前依赖于药物管理的痴呆症护理模式。

DESCRIPTION (provided by applicant): Over 5 million Americans have Alzheimer's disease or related dementias, a progressive and irreversible neurodegenerative syndrome, with prevalence rates expected to reach close to 16 million individuals by 2050. Among Veterans 65 and older, prevalence rates are similar to the population at-large with 7.3% having dementia across all races, except for African-Americans for whom the rate is 50% higher. A hallmark of dementia is neuropsychiatric symptoms (NPS; e.g., agitation, apathy, aggressiveness). NPS are associated with increased health care costs, and reduced quality of life and daily functioning, heightened family caregiver burden, and nursing home placement. Standard care typically involves pharmacologic agents, but these are at best modestly effective, carry serious risks including mortality, and do not address behavioral symptoms families themselves consider most distressful or that prompt nursing home placement. This study addresses the urgent need to develop and test innovative nonpharmacologic approaches to manage NPS in Veterans with dementia. We propose a Phase III efficacy trial to test a transformative patient-centric intervention, the Tailored Activity Program (TAP) that involves a systematic assessment to identify Veterans' preserved capabilities and deficit areas, and previous roles, habits and interests from which to tailor activities. In up to 8 home sessions over 4 months, the primary family caregiver is trained to incorporate tailored activities into daily care routines. TAP will be tested in a randomized two-group parallel design in which 160 racially and ethnically diverse Veterans with dementia and their primary family caregivers will be randomly assigned to TAP or an attention control group and interviewed at baseline, 4 and 8 months to evaluate effect on NPS, caregiver well-being and costs. Our primary study aim concerns the Veteran with dementia and tests the immediate effect of TAP at 4-months on NPS. Our hypothesis is that Veterans with dementia who receive TAP will manifest lower total scores on the Neuropsychiatric Inventory (NPI), which assesses frequency and severity of 12 common neuropsychiatric symptoms, compared to Veterans assigned to an attention control group. We also propose four secondary aims. These are to: 1) Test the long-term effects of TAP at 8-months on quality of life and neuropsychiatric behaviors of Veterans with dementia. Hypothesis: Veterans receiving TAP will manifest higher quality of life and lower total NPI scores over time (baseline to 8- months) in comparison to Veterans in the attention control group; 2) Test the immediate effects of TAP at 4-months and long-term effects at 8-months on caregiver burden, skill acquisition, efficacy using activities, and time spent providing care. Hypotheses: Caregivers receiving TAP will report reduced burden, enhanced skills and efficacy using activities, and less time providing care compared to the control group at 4, and 8-months; 3) Examine whether caregivers receiving TAP are using activities at 8 months; and 4) Examine whether TAP results in reduced VHA health care use and costs for Veterans with dementia and their caregivers. Results from these secondary aims will provide further evidence of efficacy, identify whether booster sessions are necessary, and inform dissemination efforts and translation of TAP system-wide. Our long-term objective, if proven efficacious, is to integrate TAP into standard care practices within the VHA system as the first treatment choice to address NPS in Veterans with dementia living at home. This would transform the current paradigm of dementia care which relies on pharmacologic management.